510(k) · Cleared
Recalled · Class I · 2025Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jan 31, 2003 as substantially equivalent to K910423 (Olympus Corp., 1991) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1993. 13 of the 354 devices in its family, counting itself, have a Class I recall. 350 later devices descend from it. It has been recalled 45 times, including 14 Class I recalls.
- Decided
- Jan 31, 2003
- Review
- 60 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 45 (14 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931154 (1993). 3 ancestors in all, the oldest K910423 (1991). 350 later devices descend from it, 9 citing it directly. 13 of the 354 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 1 generation backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- This deviceK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003
- Descendant · cites it directly · 159 of its ownK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 158 of its ownK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · cites it directly · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 64 of its ownK130845 Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013
Showing 5 of 350 descendants. See all descendants
Descendants cleared per year
2003high 44 (2025) · low 2 (2003)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 350 · See all- K031648Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003 · cites it directly159descendants
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · cites it directly158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 2 generations on132descendants
- K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · cites it directly73descendants
- K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013 · cites it directly64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −1 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| 0 (this device) | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | — |
| +1 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| +2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +1 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| +1 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 1 |
| 2006 | 3 | 1 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 14 | 0 |
| 2013 | 7 | 1 |
| 2014 | 13 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 9 | 0 |
| 2018 | 16 | 0 |
| 2019 | 25 | 2 |
| 2020 | 28 | 1 |
| 2021 | 21 | 1 |
| 2022 | 20 | 0 |
| 2023 | 29 | 1 |
| 2024 | 31 | 2 |
| 2025 | 44 | 2 |
| 2026 | 27 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
13 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910423 | Bronchoscope BF-N20Summary page 1…on: 21 CFR 874.4680 Bronchoscopes (flexible or rigid) and accessories, Class II *Predicate Device: BF-N20(#K910423) <Olynipus Bronchoscopes BF-240, 160 series> Trade Name: Olympus Bronchoscopes BF-240, 160 series Common… | 1991 |
| * | K963033 | BF 240/P240/IT240 Bronchovideoscope & AccessoriesSummary page 2…and accessories, Class IT * Predicate Device: BF-240, BF-P24OYBF-1 T240 (#K963033) *The difference between the predicate devices and subjects devices is only a change in material of the Biopsy Port. The change… | 1996 |
What descends from it? (350)
See all 3509 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | 2003 | 159 |
| K061313 | Evis Exera 180 System Class I | 2006 | 158 |
| K042438 | Superdimension/Bronchus | 2004 | 73 |
| K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | 2013 | 64 |
| K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary… | 2003 | 60 |
| K082720 | Tracheal Intubation Fibervideoscope, Models LF-Y0004 and LF-Y0005 | 2008 | 1 |
| K093186 | Ambu Ascope and Monitor | 2010 | 0 |
| K050220 | Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC Class I | 2005 | 0 |
| K040940 | Bronchovideoscope Olympus XBF-D160HM | 2004 | 0 |
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2025 | Class I | Z-0065-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0045-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0055-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0058-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0059-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0054-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0047-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0064-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Sep 11, 2025 | Class I | Z-0067-2026 | Device Design | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. |
| Oct 12, 2023 | Class I | Z-0189-2024 | Under Investigation by firm | There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. |
| Sep 25, 2023 | Class II | Z-0327-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Jul 27, 2023 | Class II | Z-2490-2023 | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
| Jun 8, 2023 | Class I | Z-2013-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Jun 8, 2023 | Class I | Z-2014-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Jun 8, 2023 | Class I | Z-2011-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Jun 8, 2023 | Class I | Z-2012-2023 | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. |
| Mar 8, 2022 | Class II | Z-1047-2022 | Other | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization |
| Mar 8, 2022 | Class II | Z-1046-2022 | Other | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization |
| Aug 17, 2021 | Class II | Z-2497-2021 | Under Investigation by firm | A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk. |
| Aug 16, 2021 | Class II | Z-2565-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 16, 2021 | Class II | Z-2567-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 16, 2021 | Class II | Z-2566-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 16, 2021 | Class II | Z-2568-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 16, 2021 | Class II | Z-2570-2021 | Reprocessing Controls | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Aug 8, 2018 | Class II | Z-3309-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3295-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3294-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3287-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3299-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3300-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3290-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3306-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3307-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3296-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3308-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3283-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3284-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3298-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3293-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3305-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3292-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3291-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3289-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3312-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
| Aug 8, 2018 | Class II | Z-3286-2018 | Other | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. |
The 5 latest of 45 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 16 Class I recalls
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 11 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 12 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 12 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 12 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K031648 (Olympus Optical Co., Ltd., 2003) has gone furthest, with 159 descendants of its own.
- 1 other device also cites its predicate K910423.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOQ
20in 2025
2007high 20 (2025) · low 0 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
2007high 302 (2014) · low 24 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
2007high 25 (2025) · low 0 (2007)2026
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
2007high 6,546 (2025) · low 39 (2007)2025
MAUDE reports naming product code EOQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
< BF-40 Series> These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree. <BF-240 Series> This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories…
Read the full statement (122 words)
< BF-40 Series>
These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree.
<BF-240 Series>
This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
<BF-160 Series>
These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023984
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026